20.500.12556/DKUM-26827 Optimal process mode selection for clone screening A significant amount of data is generated during clone screening procedures because several cultivation systems are used such as well-plates, shake-flasks, laboratory-scale bioreactors among others. The amount of data can often be staggering and thus requires the use of statistical and data mining procedures in order to extract hidden information. In regard to a biosimilar monoclonal antibody project, data from the shake-flask scale was observed when comparing batch and fed-batch processes for several individual clones derived from two different cell lines. The aim of the research presented in this paper was to determine if clone selection based on batch data during the initial screening phase was equivalent to the results from fed-batch selection. It was determined that fed-batch processes should be implemented early during the screening procedure, if a choice is made that the final manufacturing process should also be operated in a fedbatch mode, as clone selection based on both batch and fed-batch analytical data was divergent. Pri izboru produkcijskega klona je potrebno zbrati in ovrednotiti veliko količino podatkov, saj pri izboru uporabljamo različne gojitvene sisteme, kot so na primer ploščice z gojitvenimi jamicami, erlenmajerice, bioreaktorji itd. Obdelava vseh podatkov je ponavadi zelo dolgotrajna in pogosto je potrebno uporabiti različne matematične in statistične metode za ovrednotenje skritih informacij. V pričujočem članku smo primerjali podatke pridobljene pri gojenju skupine klonov, ki proizvajajo monoklonsko protitelo, in sicer tako šaržne rezultate kot tudi analitske rezultate pridobljene pri semi-šaržnem gojenju kulture, torej z dohranjevanjem. Cilj raziskave je bil ugotoviti ali so šaržno pridobljeni podatki ekvivalenti podatkom pridobljenih s semi-šaržnim procesom in kako te vrednosti vplivajo na izbor produkcijskega klona. Ugotovili smo, da podatki, pridobljeni z različnimi procesnimi ustroji, niso primerljivi, kar kaže na potrebo, da se v izboru produkcijskega klona uporabi tisti procesni ustroj, ki je načrtovan za samo industrijsko produkcijo. monoclonal antibody batch fed-batch clone screening glycosylation charge variants monoklonsko protitelo serija krmljena serija klonska projekcija glikozilacija različice polnjenja true false true Angleški jezik Slovenski jezik Znanstveno delo 2012-06-01 08:19:54 2012-06-01 08:19:55 2022-04-15 13:33:56 2024-01-04 03:10:48 2011 0 0 str. 333-341 št. 4 Letn. 58 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 1318-0207 602.7 14086149 15110678 1318-0207 URN:SI:UM:DK:YE1TL0EO Acta_Chimica_Slovenica_2011_Strnad_et_al._Optimal_process_mode_selection_for_clone_screening.pdf Acta_Chimica_Slovenica_2011_Strnad_et_al._Optimal_process_mode_selection_for_clone_screening.pdf 1 1ED93EEA3F575DBFB5C367273C46A721 64cdd6ca4dc92476493c63678f3628768397cb1b624cd5fd28ff6480e6da7674 388160ad-7c07-11eb-bb7a-00155d0001ca 20.500.12556/dkum/76ae5a51-c901-406c-a5f9-e7c29e982fbd https://dk.um.si/Dokument.php?lang=slv&id=115906 http://acta-arhiv.chem-soc.si/58/58-2-333.pdf 1 https://dk.um.si/Dokument.php?lang=slv&id=115905 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0